Diabetic Kidney Disease: Influence of Exercise Therapy on Physical and Vascular Function.

Not Applicable

Completed

• Conditions: Focus Type 2 Diabetes Related Chronic Kidney Disease
• Interventions: Behavioral: Exercise

• Registration Number: NCT02112071
• Lead Sponsor: University of Minnesota

Brief Summary

The general objective is to investigate the effect of a 12 week walking exercise program on vascular endothelial function, arterial stiffness/compliance, and vascular health biomarkers in men and women with pre-dialysis type 2 diabetic kidney disease (DKD).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-10
• Primary Completion: 2012-11
• Study Completion: 2013-10
• Study First Submitted: 2014-04-09
• Study First Submitted QC: 2014-04-09
• Study First Posted: 2014-04-11
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-23
• Last Update Posted: 2015-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

• • An individual must be >18 years of age

Have diagnosed type 2 diabetic mellitus by one of the following criteria:

o Treated with diet, diet plus oral hypoglycemic agents (for at least one year), or insulin preceded by treatment with oral agents (for at least one year).

If treated with insulin, the onset of diabetes must have occurred after age of 40 and the body mass index must be >25kg/m2 at the time of diagnosis.

Diagnosed kidney attributed to diabetes by one of the following criteria:3

• Macroalbuminuria (ACR >300mg/g, or)

• Microalbuminuria (ACR between 30-300 mg/g) or in the presence of diabetic retinopathy (although is recognized that about 1/3 of type 2 diabetics do not have retinopathy by fundoscopic exam).

• An elevated ACR should have been confirmed in the absence of urinary tract infections with 2 additional first-void specimens collected over 3-6 months.

• At least 2 of 3 samples should fall within the range of micro or macroalbuminuria.

  • An estimated Glomerular filtration rate (GFR) of between 90 ml/min and 30 ml/min measured by (GFR (mL/min/1.73 m2) = 186 x (Scr)-1.154 x (Age)-0.203 x (0.742 if female) x (1.210 if African-American) (conventional units).
  • Individuals must be able to provide informed consent
  • Perform walking exercise testing on a treadmill
  • Be able to participate in a 12-week supervised exercise program.

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Exclusion Criteria

• • Patients are currently exercising

  • Requiring dialysis
  • Have an Hematocrit <30%
  • Uncontrolled hypertension (>200/100mmHg)
  • Peripheral vascular disease.
  • An inability to understand English or give consent. Other exclusion criteria are: any contraindications to exercise testing or training as indicated by the American College of Sports Medicine guidelines such as: Unstable coronary heart disease and symptomatic heart failure, exercise capacity limited by health problems such as angina, severe arthritis, or extreme dyspnea on exertion, progressive neuromuscular disease, pulmonary disease., or having undergone a coronary revascularization within the past 6 months prior to enrollment.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise	Exercise	blended supervised-hombased exercise training 3-4 times/week for 12 weeks

Primary Outcome Measures

Name	Time	Method
endothelial function measured by brachial artery flow mediated vasodilation	at week 0 and at week 12	Endothelium-mediated change in in vascular tone

Secondary Outcome Measures

Name	Time	Method
Circulating markers of vascular health	at week 0 and at week 12	C-reactive protein, isoprostane F2, Asymmetric dimethylarginine
24-hour albuminuria	at week 0 and at week 12	assessed in 30 participants measured in milligram per gram creatinine
arterial stiffness measured by pulse wave velocity	at week 0 and at week 12
aerobic capacity	at week 0 and at week 12	Peak oxygen consumption
blood pressure	at week 0 and at week 12

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States